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Biological Evaluation of Medical Devices Training Course

Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices. *Includes:* Interactive workshops and discussion sessions

★★★★★ "The course was very insightful and gave me a better understanding of the process and required effort... more (12)"

15-16 January 2025
+ 15-16 May 2025, 15-16 September 2025 »
from £1099

Need help? Enrol or reserve

Format: Live online, Classroom
CPD: 12 hours for your records
Certificate of completion

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Course overview

Ensure compliance with the ISO 10993 series of standards for the biological evaluation of medical devices, as it is well-established and expected by regulatory authorities worldwide.

In the European Union, compliance with these standards is crucial for meeting the essential safety requirements outlined in the Medical Device Regulation (MDR). Understanding and implementing a comprehensive risk management strategy for biological safety is therefore paramount.

This seminar offers essential guidance on effectively utilizing the ISO 10993 standards and integrating a robust risk management approach into the biological evaluation process of medical devices. Participants will have ample opportunity to engage in interactive discussions with industry experts, gaining practical insights and best practices.

Attendees will emerge equipped with the knowledge and tools necessary to navigate regulatory requirements, mitigate risks, and ensure the safety and efficacy of medical devices in compliance with global standards.

This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.

Benefits of attending

Understand biological risk management
Clarify the requirements of ISO 10993-1
Learn what endpoints need to be addressed in a biological risk assessment
Establish how much chemical characterisation is necessary
Explore the FDA’s approach to ISO 10993
Comprehend the Medical Device Directive (MDD) safety requirements vs the Medical Device Regulation (MDR) safety requirements
Recognize how extractables and leachables impact medical device safety
Discuss the Japanese and Chinese requirements

Who should attend?

The event will be of particular importance to those in the medical device industry from the following departments:

Regulatory affairs
R&D
Product safety/toxicology
Analytical chemistry
Risk assessment and risk management
Materials research and evaluation

It will also be of interest to regulatory authorities, Notified Bodies and CROs supporting the medical device industry.

Enrol or reserve

This course will cover:

Day 1
Day 2

Introduction to biological evaluation

Overview of biocompatibility

ISO 10993 history and development / ISO 10993 structure and content

Relationship between regulatory standards

Impact of MDR

Impact of Brexit

Gap analysis of existing biocompatibility data

Medical device categorisation for biological risk assessment

Endpoints to be addressed in a biological risk assessment

GLP requirements

Lab selection

Physical and chemical characterisation

Extractables and leachables testing - when and why?

Use of QSAR

Use of data sources to and literature searching

Change management

International requirements

Gas pathway devices

Practical exercise

Enrol or reserve

Annette Callaghan
Sterile Management Systems

A quality management professional, chartered biologist and member of the Royal Society of Biology, with over 35 years’ experience in the medical device, pharmaceutical, biotechnology and food industries. Extensive knowledge of quality and environmental management systems, internal and third-party auditing and personnel training. Eligible to act as a Qualified Person as defined in Directive 2001/83/EC, as amended (previously 75/319 et al.) since 1993. A Qualified Notified Body Lead Auditor since 2002 (IRCA ref: 1182641).

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

15-16 January 2025

Live online

09:00-16:30 UK (London) (UTC+00)
10:00-17:30 Paris (UTC+01)
04:00-11:30 New York (UTC-05)
Course code 15237

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 11 Dec

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

15-16 May 2025

Live online

09:00-16:30 UK (London) (UTC+01)
10:00-17:30 Paris (UTC+02)
04:00-11:30 New York (UTC-04)
Course code 15238

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 10 Apr

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

15-16 September 2025

Classroom
Rembrandt Hotel
London

09:00-17:00 UK (London)
Timings may be different for each day
Course code 15236
Optional £255/€356/$407 per night

GBP 1,299 1,499
EUR 1,869 2,149
USD 2,137 2,449

Until 11 Aug

2 days classroom-based training
Optional accommodation - 2 nights including breakfast, checking in the day before the course
Meet presenters and fellow attendees in person
Lunch and refreshments provided
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Reviews of IPI's Biological Evaluation of Medical Devices training course

The course was very insightful and gave me a better understanding of the process and required effort. Excellent and knowledgeable speaker.

Sep 18 2023

Lambert Luong Netherlands
QA-officer, Enraf-Nonius B.V.

Sep 18 2023

Good training. I liked both the assessments and examples provided.

Sílvia Alexandra Fernandes Sweden
Chief Quality & Regulatory Officer, Nordeberg Medical AB

Sep 18 2023

My expectation were to understand the key steps of the processes and the challenges linked to each steps. It has been fully accomplished!

Cecile Artus-Arduise France
Head of Medical Affairs, LABORATOIRE HRA PHARMA

Sep 18 2023

Very knowledgeable person, who knows how to involve the attendants and make the subject more tangible. The quizzes force you to rehearse, remember and also apply the information that was given during the course.

Anne-Marie van Maurik Netherlands
QA-manager, Enraf-Nonius B.V.

Sep 18 2023

My expectation were to understand the key steps of the processes and the challenges linked to each steps. It has been fully accomplished! The training and the speaker were very great.

Cecile Artus-Arduise France
Head of Medical Affairs, LABORATOIRE HRA PHARMA

Feb 8 2022

Excellent and very informative course

Anna Gabbott United Kingdom
Regulatory Affairs Specialist, Vernacare

Feb 8 2022

Excellent and very informative course

Anna Gabbott United Kingdom
Regulatory Affairs Specialist, Vernacare

Feb 8 2022

Very informative but also personalised

Paul Fineran United Kingdom
Healthcare Technology Portfolio Project and Development Manager, University of Edinburgh

Feb 8 2022

Very detailed content and patient presenters

Elena Couzens United Kingdom
Service Development Manager, MET Limited

Feb 8 2022

the course was well presented and clear enough for a complete beginner to understand.

Sarah Hinchliffe United Kingdom
Microbiology Manager, Xiros Ltd

Oct 31 2019

I learned a lot from this course, the speakers were great and they encouraged questions from the attendees. The quiz summarized each part well. My overall opinion is very positive and I would recommend it to my colleagues.

Avital Levertov Israel
Regulatory Affairs Manager, Elcam Medical ACAL